FDA Device recall Z-0995-2024
Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGP…
- FDA Device
- Class II
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class II recall of Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGP… by Globus Medical, citing sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0995-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-11 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Globus Medical |
| Distribution | US |
Product
Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
Reason
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
Identifiers
| code_info | Lot: UDI: GBB156EB (01)00193982302238(17)300425(10)GBB156EB; GBY098JA (01)00193982302238(17)280315(…Lot: UDI: GBB156EB (01)00193982302238(17)300425(10)GBB156EB; GBY098JA (01)00193982302238(17)280315(10)GBY098JA; GBY098HA (01)00193982302238(17)280315(10)GBY098HA; GBY097FA (01)00193982302238(17)280312(10)GBY097FA; GBY098JA-RB (01)00193982302238(17)280315(10)GBY098JA-RB; GBY098HA-RB (01)00193982302238(17)280315(10)GBY098HA-RB; GBY097FA-RB (01)00193982302238(17)280312(10)GBY097FA-RB |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0995-2024%22
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